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RECRUITING Not applicable ClinicalTrials.gov

Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy

Sponsor: Dana-Farber Cancer Institute • ClinicalTrials.gov ID: NCT07548476

Registry updated: 2026-09-10
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Description

The goal of this study is to evaluate the feasibility and preliminary efficacy of a combined acupuncture and exercise intervention for the management of chemotherapy-induced peripheral neuropathy (CIPN) in participants with bladder cancer receiving enfortumab vedotin (EV) and pembrolizumab (Pembro). The names of the two study groups in this research study are: * Acupuncture + Virtual Exercise (AVE) * Virtual Exercise Only (VE)

Interventions

  • Acupuncture (Procedure)
    Acupuncture treatment with licensed acupuncturist.
  • Exercise (Behavioral)
    Virtually supervised, technology-based aerobic and resistance exercise program. Exercise bike and resistance bands will be provided to participants. Exercise sessions will be via HIPAA-compliant, teleconference platform Zoom.

Eligibility criteria

Inclusion Criteria: * Age ≥ 18 years old * Diagnosed with pathologically proven urothelial cancer (UC) * Have received at least one cycle of EV-Pembro treatment with enrollment occurring after the 1st cycle and prior to the 4th cycle * Self-reported ability to walk for 6 minutes and/or 2 blocks * Deemed acceptable for exercise by their treating provider * Sedentary, currently engaging in less than or equal to 60 minutes of moderate or vigorous structured exercise/week, as assessed by the Godin Leisure-Time Exercise Questionnaire * Willing to adhere to all study-related procedures, including randomization to either treatment group * Referrals to physical therapy are allowed during the study if necessary * Participants taking any of medications listed below must be on a stable regimen, with no changes in the past three months. Use of these medications may continue while on study. * Duloxetine, amitriptyline, nortriptyline, gabapentin, and pregabalin * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety of efficacy assessment of investigational regimen will be eligible. Exclusion Criteria: * History of documented grade 2 or greater peripheral or motor neuropathy prior to EV-Pembro initiation; may confound assessment of the intervention's preventative effect * Patients with uncontrolled medical conditions that would preclude them from participating in moderate-to-vigorous intensity exercise in a virtual setting. Given the exercise environment is virtual, only patients with stable medical conditions should be enrolled to ensure their safety. Physical Activity Readiness Questionnaire (PARQ+) will be used during screening to facilitate conversations about present or historical medical conditions * Having continued grade 2 or higher adverse effects of their current treatment (EV-Pembro) * Receiving more than 10mg prednisone daily for any condition * History of bleeding diathesis (von Willebrand disease, hemophilia A/B) * Known history of seizure disorder or taking antiepileptic drugs * Participate in more than 60 minutes of moderate or vigorous structured exercise/week Investigators will not include the following special populations: * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers \< 18 years) * Pregnant women * Prisoners

Conditions

Metastatic Bladder Cancer Peripheral Neuropathy Advanced Urothelial Cancer Metastatic Urothelial Cancer Bladder Cancer Urothelial Cancer

Locations

  • Dana Farber Cancer Institute — Boston, Massachusetts, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record